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Pharmacovigilance

Concept of Patient-Centric Pharmacovigilance

How Pharmacovigilance is incorporating the concept of Patient Centricity – An Industry-Leading Approach

Blogs, Pharmacovigilance /

In healthcare, assuring the safety of medications is equally as vital to developing innovative new treatments. Pharmacovigilance (PV), or “drug safety surveillance”, is the science of detecting, assessing, and preventing adverse drug effects or any related problems from drugs that has traditionally focused on data from healthcare providers, clinical trials and regulatory agencies. Development of […]

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Pharmacovigilance Strategies for Rare Disease Drugs

Advanced Pharmacovigilance Strategies for Rare Disease Drugs

Blogs, Pharmacovigilance /

Rare diseases (also referred to as orphan diseases) are diseases that affect less than 5 in 10,000 people in Europe or fewer than 200,000 people in the United States. Although each rare condition affects only a small population, it collectively affects more than 350 million people worldwide and can severely affect a patient’s quality of

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Risk Evaluation and Mitigation Strategies for US Drug Development

Risk Evaluation and Mitigation Strategies (REMS) for US Drug Development

Blogs, Pharmacovigilance, Regulatory /

Risk Evaluation and Mitigation Strategies (REMS) is a drug safety program required by the US FDA for certain medicines that are associated with safety concerns. They typically accompany applications to the US FDA, like New Drug Applications, Biologics License Applications, or Abbreviated New Drug Applications (ANDA), that describe drug safety and ensure that the drug’s

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Pharmacovigilance in Mexico

Exploring Pharmacovigilance Processes in Mexico

Blogs, Pharmacovigilance /

The healthcare landscape of Latin America is evolving with pharmacovigilance taking the spotlight to ensure patient safety and regulatory compliance. While there are many contenders of this region, Mexico standards out as a key player with its proactive approach to adverse event monitoring and international alignment that is shaping the future of drug safety in

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Role of AI in Literature Monitoring in Pharmacovigilance

Harnessing AI for Enhanced Literature Monitoring in Pharmacovigilance

Blogs, Medical Writing, Pharmacovigilance, Regulatory /

In the rapidly evolving landscape of pharmaceutical safety, integrating Artificial Intelligence (AI) into literature monitoring in pharmacovigilance processes has become necessary. It involves ongoing monitoring and assessment of adverse drug reactions (ADRs), and other potential risks associated with medicinal products. A critical aspect of PV is literature monitoring, which entails reviewing scientific literature, case reports, and

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Barriers medical device adverse event reporting

Identifying Barriers in Reporting Medical Device Adverse Effects

Blogs, Pharmacovigilance, Regulatory /

Medical Devices are an important part of the healthcare delivery system used in the diagnosis, monitoring, and management of diseases. Recent scientific innovations and technological solutions have expanded the use of medical devices globally. Medical devices can include items such as apparatus, instruments, appliances, substances, in-vitro reagents, software, etc. and other related objects used for

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Integrating Real-World Data into Regulatory Practices of Electronic Health Records and Medical Claims

Blogs, Pharmacovigilance, Regulatory /

As the healthcare and pharmaceutical industries increasingly turn to data-driven solutions, the integration of real-world data (RWD) into regulatory decision-making has emerged as a key focus for enhancing pharmaceutical practices. Utilizing data from Electronic Health Records (EHRs) and medical claims can provide valuable insights into patient care and treatment outcomes. This strategy has the potential

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FDA Update REMS Public Dashboard

FDA Launches REMS Public Dashboard to Enhance Transparency and Data Access

Blogs, Pharmacovigilance, Regulatory /

The U.S. Food and Drug Administration has launched the REMS (Risk Evaluation and Mitigation Strategy) Public Dashboard to enhance access to data related to REMS programs using an interactive, secure, and web-based tool. Such a dashboard will help streamline user-friendly access for health care providers, research organizations, academia, industry professionals, and the general public to

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Declaration of Helsinki 2024

Updates to the Declaration of Helsinki

Blogs, Medical Writing, Pharmacovigilance, Regulatory /

The Declaration of Helsinki (DoH), the first international set of ethical guidelines for medical research involving human participants, marked its 60th anniversary this year. The members of the World Medical Association (WMA) General Assembly gathered to and unanimously approved significant revisions to the DoH. The DoH has always established that medical research involving human participants

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Emerging Drug Safety Technology Program

Blogs, Pharmacovigilance /

Pharmacovigilance practices are associated with several challenges related to collection of safety data, processing, assessment, and volume of patient safety data. As technological disruptors- like artificial intelligence (AI)- develop, so do the solutions to tackle such challenges. This leads to more efficient pharmacovigilance (PV) systems and processes that ultimately enhance drug safety monitoring. Whether it

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